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CTRI Number  CTRI/2025/06/089057 [Registered on: 18/06/2025] Trial Registered Prospectively
Last Modified On: 17/06/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   How Neck Muscle Tension Affects Mental Health and Sleep in Working Women with Long-Term Pain? 
Scientific Title of Study   Prevalence And Associations Of Neck Muscle EMG Activity On Anxiety, Sleep Quality, And Overall Wellbeing Among Working Women With Chronic Neck Pain : A Cross-sectional Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Monika Sharma 
Designation  Ph.D. Scholar 
Affiliation  Galgotias University 
Address  Room No B-316, Department of Physiotherapy, Galgotias University, Plot No 2, Sector 17A, Opposite Buddha International Circuit, Yamuna Expy, Greater Noida.

Gautam Buddha Nagar
UTTAR PRADESH
203201
India 
Phone  8859957729  
Fax    
Email  monika0608sharma@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Monika Sharma 
Designation  Ph.D. Scholar 
Affiliation  Galgotias University 
Address  Room No B-316, Department of Physiotherapy, Galgotias University, Plot No 2, Sector 17A, Opposite Buddha International Circuit, Yamuna Expy, Greater Noida.

Gautam Buddha Nagar
UTTAR PRADESH
203201
India 
Phone  8859957729  
Fax    
Email  monika0608sharma@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Mohammad Sidiq 
Designation  Associate Professor 
Affiliation  Galgotias University 
Address  Room No B-319, Department of Physiotherapy, Galgotias University, Plot No 2, Sector 17A, Opposite Buddha International Circuit, Yamuna Expy, Greater Noida.

Gautam Buddha Nagar
UTTAR PRADESH
203201
India 
Phone  6006204628  
Fax    
Email  sidufatima@gmail.com  
 
Source of Monetary or Material Support  
Research and Development Cell, Galgotias University. 
 
Primary Sponsor  
Name  Galgotias University 
Address  Plot No 2, Sector 17A, Opposite Buddha International Circuit, Yamuna Expy, Greater Noida, India 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Monika Sharma  Galgotias University.  Room no.217 AI block, Galgotias University. Plot No 2, Sector 17A, Gautam Buddha Nagar, Uttar Pradesh, India
Gautam Buddha Nagar
UTTAR PRADESH 
08859957729

monika0608sharma@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
School Ethics Committee, SAHS, Galgotias University.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M708||Other soft tissue disorders related to use, overuse and pressure,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  55.00 Year(s)
Gender  Female 
Details  1. Working women for at least one year.
2. Having significant chronic neck pain for more than 3 months.
3. Able to understand English.
4. Willingness to participate and complete the study procedure.
 
 
ExclusionCriteria 
Details  1. History of medication for any mental, sleep and stress disorder.
2. History of medication or treatment for chronic neck pain.
3. History of anticoagulant medication such as warfarin.
4. Presence of any symptoms of any mental, sleep and stress disorder which required Doctors’ consultation.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Shimmer3 EMG activity
2. DASS 21
3. Pittsburg Sleep Quality index
4. Perceived Stress 
At Baseline only 
 
Secondary Outcome  
Outcome  TimePoints 
WHO Quality of life questionnaire  At Baseline only 
 
Target Sample Size   Total Sample Size="251"
Sample Size from India="251" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   04/07/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Chronic neck pain is a prevalent musculoskeletal issue among working women, often leading to significant disruptions in mental health, sleep quality, and overall wellbeing. This cross-sectional study aims to examine the prevalence and associations between neck muscle activity—measured through electromyography (EMG)—and psychological and physiological outcomes such as anxiety, sleep quality, and general wellbeing in this population. Working women aged 25–55 years with chronic neck pain (lasting more than three months) will be recruited. EMG assessments will be used to quantify neck muscle activity during rest and functional tasks. Standardized questionnaires including the Pittsburgh Sleep Quality Index (PSQI), DASS 21, Perceived Stress Test  and WHO-5 Wellbeing Index will be administered to evaluate sleep quality, anxiety, stress and wellbeing respectively. The objective is to explore whether abnormal neck muscle EMG activity is significantly associated with increased anxiety, poor sleep, and reduced wellbeing. By identifying these relationships, the study aims to inform integrative clinical strategies that address both physical and psychological dimensions of chronic neck pain in working women. Findings from this research could contribute to targeted interventions that reduce work-related disability and improve the quality of life for affected individuals.


 
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